Status:
COMPLETED
A Phase I Clinical Study of JS004 in Subjects With Recurrent/Refractory Malignant Lymphoma of China
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Recurrent/Refractory Malignant Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
A First-in-human, dose-escalation, dose-expansion phase I clinical study of JS004 in subjects with recurrent/refractory malignant lymphoma in China, to evaluate the safety, tolerbility, PK, immunogeni...
Eligibility Criteria
Inclusion
- Able to understand and sign informed consent voluntarily
- 18-70 years old
- Pathologically confirmed malignant lymphoma
- ECOG PS: 0-1
- Expected survival ≥12 weeks
- At least one measurable lesion per Lugano response critieria 2014 for Lymphoma
- Adequate organ and marrow function, as defined below:
- ANC≥1.5×109/L;
- PLT≥100×109/L and ≥75×109/L for subjects with bone marrow involvement;
- Hb≥90 g/L;
- TBIL≤1.5 ULN, ≤2 ULN in those with hep109atic metastasis, except subjects with documented Gilbert's syndrome who must have a baseline conjugated bilirubin ≤3.0 mg/dL;
- AST and ALT≤2.5 ULN, ≤5 ULN in those with hepatic metastasis;
- Cr≤1.5 UL, or creatinine clearance≥50mL/min for subject;
- INR ≤2 ULN and aPTT≤1.5×ULN for those with no prior anticoagulant therapy.
- According to Fridericia's principle, QTC results need to match : Male≤450 ms，Female≤470 ms
- Females of childbearing potential need to use effective contraception
Exclusion
- Patients with known allergy to macromolecular protein preparations or JS004 components
- Prior exposure to anti-BTLA or anti-HVEM antibodies
- Enrolled in other clinical studies within 4 weeks prior to the first dose of study treatment
- Major surgery within 4 weeks prior to the first dose of study treatmentor still recovering from prior surgery
- Patients who discontinued previous immunotherapy due to immune-related adverse reactions
- Immunosuppressive agents have been used within 4 weeks prior to the first dose of study treatment
- Prior allogeneic bone marrow transplantation or solid organ transplantation
- Live attenuated vaccine be administered 30 days before the first dose of study treatment
- Two or more malignancies developed within 5 years prior to first dose of study treatment
- The patients have symptomatic, untreated, or requiring ongoing treatment central nervous system (CNS) metastases
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to NCI-CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia.Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by TAB004 may be included (e.g., hearing loss) after consultation with the medical monitor.
- Autoimmune disease within the previous 2 years
- A history of rapid allergic reaction, eczema, or asthma beyond the control of topical corticosteroids
- A history of primary immunodeficiency
- Concomitant disease that is not under control, including but not limited to: persistent or active infection, unexplained fever \> 38.5°C, or heart disease, active peptic ulcer disease or gastritis
- A history of active inflammatory bowel disease
- HIV(+)
- Patients with evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Pregnant or lactating woman
- Patients with vitiligo, alopecia, and hormonal replacement therapy have controlled endocrine defects
- Any other medical factors that may affect subjects' rights, safety, compliance, ability to sign informed consent, and interpretation of study results.
- Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders.
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2024
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04477772
Start Date
July 17 2020
End Date
March 14 2024
Last Update
May 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China